Comparison Between Prepectoral and Subpectoral Breast Reconstruction

Stage II Breast Cancer Clinical Trial

— RESPECT  

Official title:

The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833659
• Other study ID #: RESPECT
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 2027

Study information

• Verified date: April 2023
• Source: Beijing Friendship Hospital
• Contact: guoxuan gao, MD
• Phone: +861063138712
• Email: aliceggx[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.

This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Description:

Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.

2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.

3. Patients having willingness for breast reconstruction.

4. Age between 18 to 70 years.

5. Maximum diameter of the cancer lesion = 3 cm.

6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.

7. The distance between the lesion and the nipple is =2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.

8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.

Exclusion Criteria:

1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.

2. Having history of malignant tumor (s) within 5 years.

3. Patients under immunosuppressive therapy for organ transplantation.

4. Having continuous systemic steroid hormone therapy.

5. Pregnant or lactating women.

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage I Breast Cancer
• Stage II Breast Cancer

Intervention

Procedure:
• The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Health Promotion Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast satisfaction	measured by BREAST-Q score	12 months after operation
Secondary	Physical well-being of chest	measured by BREAST-Q score	12 months after operation
Secondary	Animation deformity	confirmed by the doctor's physical examination	12 months after operation
Secondary	Adverse events	according to Clavien-Dindo system	within 30 days after surgery
Secondary	Local recurrence and distant metastasis of breast cancer	physical examination or imaging examination with histologically confirmed	12 months after operation